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Gx® Performance Levels

A clear structure: Gx® Performance Levels

We want to make it as easy as possible for you to find the right Gerresheimer product. That is why we have created a consistent structure with three performance levels for our vials, syringes, ampoules and cartridges:

Gx® Value
Proven solutions in pharmaceutical quality

Gx® Advance
Improved quality for higher efficiency in fill & finish.

Gx® Elite
Best-in-class quality and protection for highly sensitive drugs.

The new classification is based on an understandable systematic with increasing performance from level to level and clearly defined quality requirements and attributes for each level.

 

Gx® Value

Proven solutions in pharmaceutical quality.

Gx® Value vials, syringes, ampoules and cartridges are functional products in proven pharmaceutical quality made of type I borosilicate glass. They guarantee an efficient and cost-effective fill & finish process at all times and comply with all regulatory requirements. We produce Gx® Value products worldwide locally for the respective markets and guarantee a high level of supply availability.

Typical areas of application include heparins, generics and active ingredients for veterinary medicine.

Internationally standardized product

Full compliance to ISO standards to address pharma quality

Internationally standardized product

Full compliance to ISO standards to address pharma quality

Local-for-local supply

Secured supply chain by global availability with short lead times

Local-for-local supply

Secured supply chain by global availability with short lead times

Proven functionality

Seamless integration into all existing fill & finish equipment / proven compatibility

Proven functionality

Seamless integration into all existing fill & finish equipment / proven compatibility

State-of-the-art material

Glass tubing and polymers like COP from all major suppliers available

State-of-the-art material

Glass tubing and polymers like COP from all major suppliers available

Gx® Advance

Improved quality for higher efficiency in fill & finish

Gx® Advance products offer the properties of the Gx® Value level plus additional benefits such as tighter dimensional tolerances, reduced glass-to-glass and glass-to-metal contact and reduced cosmetic defects. If more performance and even less risk are required for fill & finish, then the products from the Gx® Advance level are the right choice. Gx® Advance Syringes and Gx® Advance Cartridges are offered as Ready-To-Fill (RTF) products.

Products and solutions from the Gx® Advance level are suitable for vaccines, small molecule drugs, or diabetes medications, for example.

Internationally standardized product

Full compliance to ISO standards to address pharma quality

Internationally standardized product

Full compliance to ISO standards to address pharma quality

Local-for-local supply

Secured supply chain by global availability with short lead times

Local-for-local supply

Secured supply chain by global availability with short lead times

Proven functionality

Seamless integration into all existing fill & finish equipment / proven compatibility

Proven functionality

Seamless integration into all existing fill & finish equipment / proven compatibility

State-of-the-art material

Glass tubing from all major suppliers available

State-of-the-art material

Glass tubing from all major suppliers available

Improved fill & finish efficiency

Improved product quality leads to less defects on fill & finish lines with improved performance and reduced TCO

Improved fill & finish efficiency

Improved product quality leads to less defects on fill & finish lines with improved performance and reduced TCO

Higher product quality

Tighter AQLs (reduced vial-to-vial and vial-to-metal contact) lead to reduced cosmetic defects. Increased dimensional consistency for all products.

Higher product quality

Tighter AQLs (reduced vial-to-vial and vial-to-metal contact) lead to reduced cosmetic defects. Increased dimensional consistency for all products.

Advanced system variety

Additional system features like surface treatment and elastomer components etc. are available

Advanced system variety

Additional system features like surface treatment and elastomer components etc. are available

Gx® Elite – Best-in-class quality and protection for highly sensitive drugs.

Gx® Elite vials, syringes and cartridges offer all the advantages of the Gx® Advance level plus significantly higher breakage resistance, absolutely consistent dimensional tolerances and a flawless appearance thanks to no glass-to-glass and minimized glass-to-metal contact during manu­facturing and transport. All products in the Gx® Elite level can be supplied in a Ready-To-Fill (RTF) version. Gerresheimer offers the EZ-fill or EZ-fill Smart™ packaging platform. From mid 2024 EZ-fill Smart™ packaging will be available with environmentally friendly VHP sterilization. Comprehensive data packages are also available upon request.

These highest quality products and solutions are ideal for sensitive drugs and biologicals, mRNA vaccines, gene therapy drugs and active ingredients used in ophthalmology and aesthetic medicine.

Internationally standardized product

Full compliance to ISO standards to address pharma quality

Local-for-local supply

Secured supply chain by global availability with short lead times

Proven functionality

Seamless integration into all existing fill & finish equipment /proven compatibility

State-of-the-art material

Glass tubing and polymers like COP from all major suppliers available

Improved fill & finish efficiency

Superior product quality leads to less defects on fill & finish lines with improved performance and reduced TCO

Superior product quality

Tighter AQLs (reduced vial-to-vial and vial-to-metal contact) lead to no visible defects, scratches or contamination. No glass-to-glass contact for tube processing. Best dimensional consistency for all products.

Advanced system variety

Additional system features like surface treatment and elastomer components available

Optimized TCO

Improved performance on fill & finish lines leads to optimized TCO (lower running / lower overall costs for customers)

Highest compatibility for sensitive drugs

Extractables testing data, fulfils sophisticated pharmaceutical requirements

Comprehensive data packages available

System performance and compatibility data available including data for pharmaceutical requirements.

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Leading system and solution provider: Components, treatments and services

Thanks to the three performance levels Gx® Value, Gx® Advance and Gx® Elite, you can find the right solution for your needs quickly and easily. In addition, we provide our products as a complete system with a great variety of components, treatments and services that guarantee a perfect match with our standard products within the three performance levels.

We offer you suitable caps & closures for vials and cartridges, tailored to your requirements. We supply our syringes with high-quality components and accessories including closure systems, needle shields, plunger stoppers, plunger rods and backstops.

All components offered meet the highest requirements in terms of safety and user-friendliness. Depending on the application and the fill & finish process, they vary in sizes, formulation, and design.

Special coatings can be used to provide the glass surface with additional protection against mechanical influences. The innovative Velocity® Vial – available from the Gx® Advance performance level onwards – comes with an outer coating to reduce frictional resistance and thus significantly increases the efficiency of the filling process. Moreover, we offer diverse siliconization options such as spray and baked-on, but also for example silicone-free syringes. Individual options, such as an ammonium sulfate treatment for an enhanced surface resistance, complete the range.

The Gerresheimer traceability system enables complete traceability of our products throughout the value chain: from primary packaging to secondary packaging, and from drug filling and serialization up to the final application at the PoC. Therefore traceability helps to increase patient safety and fight counterfeiting. Data can be linked to individual products, analyzed and evaluated via our powerful digital infrastructure.

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Gx Performance Level - Gerresheimer AG

Contact the expert

Holger Krenz

 

Global Vice President
Business Development High Value Products
Tubular Glass

holger.krenz-remove@remove-gerresheimer.com

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